Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD).
Ann Clin Transl Neurol
; 8(2): 308-320, 2021 02.
Article
in English
| MEDLINE | ID: covidwho-985903
ABSTRACT
OBJECTIVE:
The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site-centric therapeutic trials in Parkinson's disease and generate novel insights. The value of this approach has never been more evident than during the current COVID-19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow-up of clinical trial participants, (2) compare changes in smartphone-based assessments, online patient-reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson's disease disability and progression.METHODS:
Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease trials (AT-HOME PD), a two-year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone-based assessments of motor function and socialization, and patient-reported outcomes online.RESULTS:
From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study's smartphone application and 161 (71%) have completed patient-reported outcomes on the online platform.INTERPRETATION:
It is feasible to conduct a large-scale, international virtual observational study following the completion of participation in brick-and-mortar clinical trials in Parkinson's disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow-up of clinical trial participants and design of future clinical trials.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Parkinson Disease
/
Research Design
/
Telemedicine
/
Videoconferencing
/
Mobile Applications
/
Smartphone
/
Patient Reported Outcome Measures
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Ann Clin Transl Neurol
Year:
2021
Document Type:
Article
Affiliation country:
Acn3.51236
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